Orgovyx to be used for treatment of advanced hormone-sensitive prostate cancer in Europe
Intas Pharmaceuticals Ltd’s arm, Accord Healthcare Ltd, has entered into an exclusive license agreement with UK-headquartered biotech player Myovant Sciences to provide a new treatment option for prostate cancer patients in Europe.
The agreement will commercialise relugolix for the treatment of advanced hormone-sensitive prostate cancer under the brand Orgovyx (relugolix, 120 mg) in the European Economic Area, the UK, Switzerland and Turkey. There is also a provision for the right of first negotiation if Myovant decides to enter into licensing arrangements in countries in West Asia, Africa and India.
Under the terms of the agreement, Myovant will receive an upfront payment of $50 million and is eligible to receive commercial launch, sales-based and other milestones totaling up to $90.5 million, an official statement said.
In addition, Myovant is eligible to receive tiered royalties from the high-teens to mid-twenties on net sales. Myovant will continue to lead the global development of relugolix and provide initial product supply to Accord.
Intas-arm Accord will be responsible for local clinical development, commercialisation for its territories, and has the option to manufacture relugolix in the future.
Chief Executive Officer, Myovant, David Marek said, “We’re delighted to join forces with Accord to make available the first and only oral androgen deprivation therapy for men with advanced hormone sensitive prostate cancer, in Europe.” Accord will accelerate the launch to reach more patients with this therapy.
Binish Chudgar, Managing Director of Accord, said, “We are proud to launch Orgovyx in Europe, as an addition to our specialty brand offerings.”
He added that Accord currently supplies around 1 in 3 injectable oncology medicines in Europe and “this agreement underpins our commitment to patients with cancer and our continued investment in novel therapies. With over 1.9 million men living with prostate cancer in Europe, our partnership with Myovant will provide men living with hormone-sensitive advanced prostate cancer a new oral treatment option.”
On April 29, 2022, the European Commission had approved the marketing authorisation application for Orgovyx (relugolix, 120 mg) for the treatment of adult patients with advanced hormone-sensitive prostate cancer.
The decision applies to all 27 European Union member states, besides Iceland, Norway, and Liechtenstein.
The marketing authorisation application for Orgovyx is pending review by the UK Medicines and Healthcare Products Regulatory Agency (MHRA). Accord expects to launch Orgovyx in Europe in the second half of calendar year 2022.
Goldman Sachs & Co. LLC acted as the exclusive financial advisor to Myovant and Sidley Austin LLP represented Myovant in the transaction, the statement said.